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The Efficacy of N-acetylcysteine Versus Placebo for the Treatment of Metamphetamine Withdrawal Symptoms

M

Melva Louisa

Status and phase

Completed
Phase 3
Phase 2

Conditions

Methamphetamine Dependence in Remission

Treatments

Drug: Placebo
Drug: N-acetyl cysteine

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

Up to date, no approved medications are available for the treatment of methamphetamine addiction. Recently, N-acetylcysteine is recently being studied for methamphetamine withdrawal.

N-acetylcysteine, is a drug that has been long used as a mucolytic. Recent studies investigate the use of N-acetylcysteine in cocaine and withdrawal symptoms by its effect on restoring glutamate homeostasis in nucleus accumbens. Up to date, there has been 2 pilot study investigating the efficacy of N-acetylcysteine for methamphetamine dependence.

The present study is aimed to confirm the efficacy and safety of N-acetylcysteine in the treatment of methamphetamine withdrawal symptoms.

Full description

Methamphetamine is a stimulant commonly abused worldwide. Methamphetamine can produce a rapid pleasurable rush caused by release of dopamine, nor-ephinephrine and serotonin. It produces euphoria, a heightened level of alertness and increased level of alertness and increased energy. Long-term regular meth use can lead to severe tooth decay, infection, weight loss, malnutrition, kidney damage, liver damage, respiratory issues, paranoia, violent behaviour, psychosis, severe anxiety and depression.

Studies suggested that withdrawal symptoms in methamphetamine dependent patients were due to the state of hypodopaminergic activities.

Up to date, no approved medications are available for the treatment of methamphetamine addiction. Recently, N-acetylcysteine is recently being studied for methamphetamine withdrawal.

N-acetylcysteine, is a drug that has been long used as a mucolytic. Up to date, there has been 2 pilot study investigating the efficacy of N-acetylcysteine for methamphetamine dependence. The present study is aimed to confirm the efficacy and safety of N-acetylcysteine in the treatment of methamphetamine withdrawal symptoms.

Enrollment

66 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Men or women, 18 - 60 years old
  • Diagnosed with methamphetamine addiction based on DSM-V criteria, enrolling for methamphetamine withdrawal treatment
  • Agree to participate in the trial by signing informed consent

Exclusion criteria

  • Known hypersensitivity to N-acetylcysteine
  • Patients with serious conditions that will not allow protocol compliance or safe participation in the clinical trials.
  • Pregnant or breastfeeding women
  • History of suicidal thoughts / behaviour
  • History of N-acetylcysteine treatment
  • History of asthma and convulsions

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

66 participants in 2 patient groups, including a placebo group

Treatment
Experimental group
Description:
2 capsules, each containing 600 mg N-acetylcysteine administered once daily every morning.
Treatment:
Drug: N-acetyl cysteine
Placebo
Placebo Comparator group
Description:
2 capsules of matching placebo administered once daily every morning
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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